Most ASRs are classified as Class I and exempt from the agency's 510(k) premarket notification requirements. ASRs are classified in Class II or Class III when intended for use in blood banking, donor screening, and certain infectious disease testing. (FDA regulations for human blood and blood components require that tests used by establishments for these applications be approved by FDA. Accordingly, home-brew tests used in blood banking and donor screening require FDA clearance, approval, or licensure. Regardless of classification, all ASR manufacturers must comply with FDA's postmarket requirements, including establishment registration, device listing, and compliance with FDA's quality system regulation (QSR), medical device reporting (MDR) requirements, and ASR labeling and distribution requirements.
The ASR requirements also extend to the clinical laboratories that purchase and use ASRs to develop home-brew tests (i.e. tests that are ordered on a prescription basis). Specifically, laboratories that prepare in-house tests using an ASR purchased from a third-party supplier are required to append the following statement to the test report: “This test was developed and its performance characteristics determined by [Laboratory Name]. It has not been cleared or approved by the U.S. Food and Drug Administration.” (It seems illogical and perhaps even misleading for FDA to require a statement that an assay has not been cleared or approved when the agency itself does not require the assay to be cleared or approved. By classifying them as Class I, FDA exempted most ASRs from 510(k) clearance requirements and, in turn, decided not to regulate in-house tests that are prepared from these ASRs. It makes little sense, then, to require clinical laboratories to warn physicians that the testing services were developed without FDA review. It would be more accurate to observe that the agency does not require such clearance or approval).
The "qualified facility" is simply a clinical laboratory that is subject to CLIA regulation. Since no pre-market clearance or approval of a Class I device (e.g. an ASR) is required, there is no "FDA review" of the sale of the ASR by the regulated laboratory.
